NCT07279493

Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase Ⅱb Clinical Trial to Evaluate the Efficacy and Safety of the KPCXM18 Injection at Different Doses in The Treatment of Acute Ischemic Stroke

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Kunming Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.

Detailed description

Trial Objectives: The primary objective is to evaluate the efficacy of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke. The secondary objective is to evaluate the safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke and based on the population pharmacokinetic analysis method, explore the PK characteristics of the KPCXM18 injection in patients with acute ischemic stroke, and provide a basis for the design of the phase III clinical study. Trial Design: This trial is a multicenter, randomized, double-blind, parallel, placebo-controlled design. The subjects will be randomly assigned to the low-dose group, the high-dose group, and the placebo group at a ratio of 1:1:1, with 100 subjects in each group, totaling 300 subjects. The treatment will be administered continuously for 12±2 days to explore the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	The KPCXM18 injection	Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 12±2 days.
DRUG	Placebo	Intravenous infusion twice a day with an interval of 12±2 hours for 12±2 days.
DRUG	The KPCXM18 injection	Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 12±2 days.

Timeline

• Start date: 2025-11-22
• Primary completion: 2026-10-18
• Completion: 2026-10-18
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

23 sites across 1 country: China